Data Foundry

Medical device recalls 2013

Sonopet Ultrasonic Aspirator Console 5450-851-000 — Class II medical device recall Z-1879-2013

Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2013-08-14, distributed nationwide. A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles liste

Recall numberZ-1879-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStryker Instruments Div. of Stryker Corporation, Portage, MI, United States
Recall initiated2013-06-24
Classified2013-08-05
Reported by FDA2013-08-14
Terminated2014-01-30
DistributedNationwide (US)
Countries outside the USAU, CA, CH, GB, HK, IN, IT, JP, NL, NZ, TW
Quantity215 units

Product

Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.

Reason for recall

A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply sali

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1879-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.